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Test Code QFTB QuantiFERON-TB Gold Plus, Blood

Useful For

Indirect test for Mycobacterium tuberculosis infection.  Use in conjunction with risk assessment and other medical and diagnostic findings.

Specimen Requirements

5.0 mL of refrigerated Sodium Heparin Whole Blood;  DO NOT CENTRIFUGE

Preferred:  Two 4.0 mL sodium heparin, refrigerated

Acceptable:  Two 3.0 mL lithium heparin, refrigerated

Reference Values

Negative

Day(s) Test Set Up

M-F

No collection after noon on Friday due to required aliquoting and incubation.

Specimen Stability

Refrigerated:  48 hours

Performing Laboratory

Huntsville Hospital Laboratory

Methodology

Chemiluminescence Immunoassay

Interpretation

Positive:

       Interferon-gamma (IFN-gamma) response to Mycobacterium tuberculosis antigens detected, suggesting infection with M tuberculosis. Positive results in patients at low-risk for TB should be interpreted with caution and repeat testing on a new sample should be considered recommended by the 2017 American Thoracic Society, the Infectious Diseases Society of America, the Centers for Disease Control and Prevention (ATS/IDSA/CDC) Clinical Practice Guidelines for Diagnosis of Tuberculosis in Adults and Children.(1) False-positive results may occur in patients with prior infection with Mycobacterium marinumMycobacterium szulgai, or Mycobacterium kansasii.

Negative:

       No IFN-gamma response to M tuberculosis antigens was detected. Latent infection with M tuberculosis is unlikely. A single negative result does not exclude infection with M tuberculosis. In patients at high risk for M tuberculosis infection, a second test should be considered in accordance with the 2017 ATS/IDSA/CDC Clinical Practice Guidelines for Diagnosis of Tuberculosis in Adults and Children.(1)

 Indeterminate due to Low Mitogen Value:

        Indeterminate results due to a low IFN-gamma level in the mitogen (positive control) tube. This may occur due to a low lymphocyte count, reduced lymphocyte activity, or inability of the patient's lymphocytes to generate IFN-gamma.

Indeterminate due to High Nil value:

        Indeterminate results due to a high level of IFN-gamma in the Nil (negative control) tube. This may occur due to heterophile antibody effects or nonspecific, circulating IFN-gamma in the patient's blood sample. Repeat testing on a new specimen is suggested.

CPT Coding

86480

Secondary ID

HHA 1607